Device and system for augmenting a heart

ABSTRACT

A radially compressible cardiac gripper for at least mechanical stimulation of a heart. The cardiac gripper has two gripper arms, wherein at least one of the gripper arms comprises a flexible section configured for movement of the arm having the flexible section.

FIELD OF THE INVENTION

This disclosure pertains in general to the field of augmenting a heart.More particularly, the disclosure relates to a device and system forperforming mechanical and/or electrical augmentation of a heart.

BACKGROUND OF THE INVENTION

Today different cardiac augmenting methods and devices are known, suchas cardiopulmonary resuscitation (CPR) and a ventricular assist device(VAD).

When CPR is performed it can lead to complications that may need to berectified. Common complications due to CPR are rib fractures, sternalfractures, bleeding in the anterior mediastinum, heart contusion,hemopericardium, upper airway complications, damage to the abdominalviscus, fat emboli, pulmonary complications—pneumothorax, hemothorax,lung contusions and so on. Additionally, in order to augment the heartwith CPR over a longer time it preferably requires a number of people toconduct the CPR with a similar force due to each person becomingphysically tired. Further, the CPR needs to be performed when a personis laying down on his/her back on a solid ground.

VADs are sometimes intended for short term use, typically for patientsrecovering from heart attacks or heart surgery, while others areintended for long-term use, typically for patients suffering fromadvanced congestive heart failure. VADs are designed to, mechanically bypumping, assist either the right (RVAD) or left (LVAD) ventricle, orboth ventricles at once (BiVAD).

Known VADs are however constructed as complex devices which are quiteintricate to implant into a patient. Thus, VADs are time consuming toimplant and require surgeons and other highly trained clinical personalto implant them.

Further, since the VADs are connected directly to the blood stream forpumping the blood they also have common associated problems for deviceswith blood contact such as coagulation associated problems.

The VADs also have the problem of having moving parts, in particularsupported by bearings, i.e parts which can fail and need to bereplaced—which is complicated in an implanted device like a VAD.

Thus, a device, method and/or system which overcome the above drawbackswould be advantageous.

SUMMARY OF THE INVENTION

Accordingly, examples of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device and a system for performing augmentingaccording to the appended patent claims.

According to a first aspect of the disclosure, a radially compressiblecardiac gripper for at least mechanical stimulation of a heart, whereinthe cardiac gripper comprises two gripper arms, and wherein at least oneof the gripper arms comprises a flexible section configured for movementof the arm is disclosed.

According to a second aspect of the disclosure, a cardiac augmentingsystem comprising a radially compressible cardiac gripper for at leastmechanical stimulation of a heart, wherein the cardiac gripper comprisestwo gripper arms, and wherein at least one of the gripper arms comprisesa flexible section configured for movement of the arm and a means forpressurizing the cardiac gripper connected thereto.

Further examples of the disclosure are defined in the dependent claims,wherein features for the second and subsequent aspects of the disclosureare as for the first aspect mutatis mutandis.

Some examples of the disclosure provide for at least mechanicalstimulation of the heart.

Some examples of the disclosure provide for an easy and reliable way togive mechanical stimulation for a long time.

Some examples of the disclosure are provided to (mechanically) assistthe heart in its natural contractions and/or expansions.

Some examples of the disclosure are provided to improve and/or torestore a heart's movement (or a heart's blood pumping function) to anormal (related) degree of contraction and/or expansion.

Some examples of the disclosure provide for a radial compression whichis low magnitude and/or force of pressure on the heart.

Some examples of the disclosure provide for a radial compression whichis high in magnitude and/or force of pressure on the heart.

Some examples of the disclosure provide for a mechanism that allows foreasy movement outwards and/or inwards for mechanically augmenting theheart.

Some examples of the disclosure provide for a space constrained movementmechanism.

Some examples of the disclosure provide for mechanical augmenting of theheart in a limited space, such as the inside of the thoracic cavity orpericardial cavity.

Some examples of the disclosure provide for not introducing any force toheart when the assist device is not functioning properly.

Some examples of the disclosure provide for a robust but still with alight weight construction.

Some examples of the disclosure provide for a device being flexible in adirection of corrugation and stiff in a direction perpendicular to thedirection of corrugation.

Some examples of the disclosure provide for a better grip of the heartwhen augmenting the heart.

Some examples of the disclosure provide for a larger area of contactwith the heart and thus the better grip.

Some examples of the disclosure provide for an attachment means tofurther improve the grip.

Some examples of the disclosure provide for attaching a device or partof a device to the heart without damaging the heart.

Some examples of the disclosure provide for a curvature giving a bettergrip when encompassing the heart and augmenting the heart.

Some examples of the disclosure provide for not damaging the heartmechanically.

Some examples of the disclosure provide for that a single diameter canbe manufactured and/or selected in an emergency situation.

Some examples of the disclosure provide for a minimal damage wheninserted around the heart for the mechanical stimulation.

Some examples of the disclosure provide for easy insertion around theheart.

Some examples of the disclosure provide for a pressure of a fluid willbe quickly distributed.

Some examples of the disclosure provide for a best possible expansionand/or contraction.

Some examples of the disclosure provide for an ease of deployment.

Some examples of the disclosure provide for a pressure being moreuniformly distributed.

Some examples of the disclosure provide for affecting an armsubstantially simultaneously for pushing and/or pulling the arms awayand/or together.

Some examples of the disclosure provide for acting as steering means.

Some examples of the disclosure provide for no leakage.

Some examples of the disclosure provide for booth handling andpressurisation.

Some examples of the disclosure provide for easy and more secureguidance into place around the heart.

Some examples of the disclosure provide for a stabile device.

Some examples of the disclosure provide for a self-balanced device.

Some examples of the disclosure provide for no need to produce a counterforce, such as a torque or a twisting motion.

Some examples of the disclosure provide for a device arranged to accountfor an angled insertion.

Some examples of the disclosure provide for a device adapted toelectrically stimulate and/or sense the electrical activity of theheart.

Some examples of the disclosure provide for a device configured to treatelectrical conduction problems of the heart.

Some examples of the disclosure provide for measuring an intrinsic heartaction.

Some examples of the disclosure provide for a device which supplants therest of a mechanical or electrical, or in combination of, needed toobtain a normal cardiac output at rest or during exercise.

Some examples of the disclosure provide for a device configured for acardioversion.

Some examples of the disclosure provide for a response to the pressureof the heart.

Some examples of the disclosure provide for sensing a counterforce.

Some examples of the disclosure provide for imaging.

Some examples of the disclosure provide for improved electrical contact.

Some examples of the disclosure provide for augmentation to be performedat any position around the heart.

Some examples of the disclosure provide for therapy can be performed atany position of the heart's surface.

Some examples of the disclosure provide for augmentation of the heartover a large area of the heart.

Some examples of the disclosure provide for individual augmentation.

Some examples of the disclosure provide for augmentation at differentareas at, different times at different areas.

Some examples of the disclosure provide for augmentation at the same thetime at different areas.

Some examples of the disclosure provide for mapping in 4D.

Some examples of the disclosure provide for finding inhomogenities whichpoint to a source of fibrillation.

Some examples of the disclosure provide for ablation.

Some examples of the disclosure provide for detection of points to weakactivation triggers in the heart.

Some examples of the disclosure provide for a device in emergencysituations.

Some examples of the disclosure provide for a simple and quick insertionat the ribs.

Some examples of the disclosure provide for a deployment of a device orsystem by physicians and non-physicians within and outside the hospital.

Some examples of the disclosure provide for less invasive approaches.

Some examples of the disclosure provide for storing a part of a systemabove the stomach in the abdominal fat.

Some examples of the disclosure provide for an automated mechanicalaugmenting of the heart.

Some examples of the disclosure provide for a relaxed state such that adevice or system does not introduce any force to the heart when thedevice or system is not in operation or not functioning.

Some examples of the disclosure provide for a cheap, compact and yetreliable heart function augmentation system.

Some examples of the disclosure provide for a reciprocating movement forheart support.

Some examples of the disclosure provide for an analysis in fourdimensions, including time and a three-dimensional space.

Some examples of the disclosure provide for an alternatingpressurization of a heart.

Some examples of the disclosure provide for a cardiac assist controlbased on pressure.

Some examples of the disclosure provide for a reciprocating squeezingmovement on the heart for stimulating it.

Some examples of the disclosure provide for electrically stimulating theheart and/or means for detecting an electrical signal of the heart.

Some examples of the disclosure provide for treating electricalconduction problems of the heart.

Some examples of the disclosure provide for treating different kinds ofelectrical conduction problems automatically.

Some examples of the disclosure provide for controlling on a measuredelectrical activity of the heart and/or ECG.

Some examples of the disclosure provide for transmitting and/orreceiving energy and/or data.

Some examples of the disclosure provide for a battery charging of theaugmenting system.

Some examples of the disclosure provide for a telemetry component.

Some examples of the disclosure provide for automatic self-controland/or messaging and/or error messaging such as alert of replacement ofa component, low heart pump function and other interesting common heartparameters or parameters of the device.

Some examples of the disclosure provide for an augmenting systemcompletely implanted in a patient.

Some examples of the disclosure provide for a device produced with a 2Dprinter from biocompatible plastic.

Some examples of the disclosure provide for a device visible duringX-ray, MRI and/or other imaging techniques.

Some examples of the disclosure provide for a method of temporarilytreatment of the heart by at least augmentation.

Some examples of the disclosure provide for a method comprisingaugmenting the heart at systole and/or diastole.

Some examples of the disclosure provide for augmentation based on acontrol signal and the control signal is based on a sensor measurement.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which examples ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of examples of the present disclosure, referencebeing made to the accompanying drawings, in which

FIG. 1 is a schematic side view of an example of a cardiac augmentingdevice comprising at least one flexible gripper arm.

FIG. 2 is a schematic top view of an example of a cardiac augmentingdevice comprising at least one flexible gripper arm.

FIG. 3 is a schematic view of a cardiac augmenting system comprising acardiac augmenting system and means for pressurising the cardiacaugmenting system.

FIG. 4 is a schematic side view of a cardiac augmenting systemcomprising a cardiac gripper and means for pressurising the cardiacgripper. And, wherein the means for pressurising are illustrated in twoof its pumping states, full and empty.

FIG. 5 is a flowchart of a method for augmenting using a cardiacaugmenting system.

DETAILED DESCRIPTION OF THE INVENTION

Specific examples of the disclosure now will be described with referenceto the accompanying drawings. This disclosure may, however, be embodiedin many different forms and should not be construed as limited to theexamples set forth herein; rather, these examples are provided so thatthis disclosure will be thorough and complete, and will fully convey thescope of the disclosure to those skilled in the art. The terminologyused in the detailed description of the examples illustrated in theaccompanying drawings is not intended to be limiting of the disclosure.In the drawings, like numbers refer to like elements.

The following description focuses on an example of the presentdisclosure of a device for augmenting applicable to an organ and inparticular to a heart. However, it will be appreciated that thedisclosure is not limited to this application but may be applied to manyother organs that pump or circulate fluids in a body including forexample a lung. A “cardiac” gripper may thus be used for other organs asthe heart, like a lung, for mechanical support thereof like the onedescribed for the heart herein below.

Illustrated in FIG. 1, is an example of a radially compressible cardiacgripper 1 for at least mechanical stimulation of a heart. By having aradially compressible cardiac gripper 1 it is possible to give at leastmechanical stimulation in an easy and reliable way for a long time.

Thereby, the cardiac gripper 1 is adapted to assisted the heart in itsnatural contractions and/or expansions and/or the heart can even beimproved to restore it's movements to a normal degree of contractionand/or expansion if damaged. In an example, the cardiac gripper's 1radial compression is low in magnitude and/or force since the pressureof the heart is low or high. In an example, the cardiac gripper's 1radial compression is high in magnitude and/or force since the pressureof the heart is low or high.

In an example, the cardiac gripper 1 comprises two gripper arms 2 andwherein at least one of the gripper arms 2 comprises a flexible section3 configured for movement of the arm 2. By having the gripper arms 2comprising the flexible sections 3, the gripper arms 2 have a mechanismthat allows the arms 2 to move easily outwards and/or inwards formechanically augmenting the heart. In an example, the flexible section 3is a concertinaed section. In an other example (not shown) only one ofthe gripper arms has such concertinaed section.

By having the concertinaed section 3 the gripper arms 2 have a spaceconstrained movement mechanism built into the arms 2 which make themcapable of moving outwards and/or inwards for mechanically augmentingthe heart in a limited space, such as the inside of the thoracic cavityor pericardial cavity.

In an example, the cardiac gripper 1 is configured to have relaxed arms2 such that they do not introduce any force to heart when notfunctioning, i.e. so that no harm is induced to the heart if the gripper1 would fail.

In an example, at least one of the gripper arms 2 comprises a corrugatedsection 4. By having the corrugated section 4 the at least one arm 2 aremade robust but still with a light weight construction.

In an example, the corrugated section 4 is flexible in a direction ofcorrugation and stiff in a direction perpendicular to the direction ofcorrugation.

In one example, the corrugations are described in terms of pitch (thedistance between two crests) and depth (the height from the top of acrest to the bottom of a trough).

In an example, the pitch is between 1-15 and the depth is 1-50 mm and inan example the pitch is 5 and the depth is 2.5 mm. In another example,the corrugations are constructed of triangular solid and/or hollowtriangular shapes, as e.g. illustrated in FIGS. 1-2. Other types ofknown shapes for constructing the corrugation are also possible such as,rectangular, sinusoidal and/or squared.

In an example, e.g. illustrated in FIGS. 1-2, at least one of thegripper arms 2 comprise a sinusoidal surface 5, and wherein thesinusoidal surface 5 is angled towards a centre point of the cardiacgripper 1. By having the sinusoidal surface 5 the at least one gripperarm 2 will have a better grip of the heart when augmenting the heartfunction. The sinusoidal surface 5 makes the gripper arms 2 have alarger area of contact with the heart and thus the better grip.

In an example, the epicardium or another location of the heart isattached to the cardiac gripper 1 by an attachment means to furtherimprove the grip between the cardiac gripper 1 and the heart. Suchattachment means is e.g. at least one suction cup, hook, glue or otherknown attachment means for attaching a device or part of a device to theheart without damaging the heart.

In an example, at least one of the gripper arms 2 are curved for abetter grip when encompassing the heart and augmenting the heart. In anexample, the curvature of the gripper arms 2 is chosen to be based onthe interesting areas of compression, expansion and/or contraction ofthe heart. In an example, the curvature of the gripper arms 2 are chosensuch that when the ends of the gripper arms 2 contact each other duringthe compression of the heart, the gripper arms 2 do not damage the heartmechanically, i.e. the inner diameter between the gripper arms 2 of thegripper 1 are larger than or substantially the same as a diameter of theheart, such as 60-80 mm.

Hence, a free space of the cardiac gripper 1 is equal to or larger thanthe diameter of the heart so that the augmentation device 1 cannotdamage the heart by pushing the gripper arms 2 too tight around theheart when providing a maximum contraction.

In addition or alternatively this means that the gripper arms 2 areconfigured to be have a stop of the motion when being in contact withtheir respective ends as e.g. illustrated in FIGS. 1 and 3.

In an example, the diameter of the gripper 1 is chosen to be equal to orlarger than a diameter that is considered to be safe for most patientswithout damaging the heart of the same, such that a single diameter canbe manufactured and/or selected in an emergency situation.

In an example, at least one gripper arm 2 is blunt at an end of thegripper arm 2. By having at least one gripper arm 2 blunt, or atraumaticat an end the gripper arm 2 will induce a minimal damage when insertedaround the heart for the mechanical stimulation, as e.g. illustrated inFIG. 1.

In an example, at least one end of the gripper arm is angled at the endof the gripper arm. By having the at least one end of the gripper armangled the gripper arm 2 is easily inserted around the heart since theheart will be pushed into the centre of the gripper 1 and thus be aidedby the angled end of the gripper arms 2, as e.g. illustrated in FIG. 1.

In an example, the cardiac gripper 1 comprises a fluid channel having aninlet 6 and wherein the inlet 6 is arranged at the gripper arms 2, e.g.illustrated in FIG. 2. By having the gripper 1 comprising the inlet 6and the inlet 6 being arranged at the gripper arms 2, a pressure of afluid in the fluid channel will be quickly distributed in the fluidchannel in the arms 2 for pushing together or pulling away the gripperarms 2 from each other. In an example, the inlet 6 is adapted to bearranged anywhere on the cardiac gripper 1 for a best possible expansionand/or contraction of the gripper arms 2, ease of deployment of thegripper 1 and/or stability of the cardiac gripper 1.

In an example, the inlet 6 is arranged at a centre between the gripperarms 2. By having the inlet 6 at the centre between the gripper arms 2,a pressure from a fluid entering into the inlet 6 will be more uniformlydistributed in the fluid channel in the arms 2 and thus affect the arms2 substantially simultaneously for pushing and/or pulling the arms 2away and/or together.

In an example, the fluid channel is integrated with and extending awayfrom the cardiac gripper 1. In an example, the fluid channel isintegrated with and extending away from the cardiac gripper 1 at thecentre between the gripper arms 2. By having the fluid channelintegrated with and extending away from the centre between the flexiblesections 2, the fluid channel can also act as steering means for thecardiac gripper 1.

Further, there will be no leakage of the fluid at the gripper arms 2. Inan example, the fluid channel is integrated with or coupled to asteering means such as a catheter, clamping device and other knownsteering devices such that booth handling, navigation and pressurisingthe cardiac gripper 1 is achieved.

In another example, the cardiac gripper 1 comprises an open end andwherein the open end is opposite of a centre between the gripper arms 2,i.e. the joining of the arms as illustrated in e.g. FIG. 1.

By having the open end opposite the centre of the gripper arms 2, thegripper arms 2 can more easily and more securely be guided into placearound the heart since the opening of the gripper 1 is arranged in asteering direction. Further, the cardiac gripper 1 is more stable whenopening and closing since the cardiac gripper 1 is more or lessself-balanced. Thus, an operator and/or other device steering and/orholding the cardiac gripper 1, does not need to produce a counter force,such as a torque or a twisting motion for holding the cardiac gripper 1and the heart at its desired location.

In an example, the opening of the gripper 1 is adapted for a desiredentrance point of the gripper 1 into a human or animal. Thus, theopening will be arranged such that the gripper 1 is inserted in e.g. anangle and the operator can just follow the angled direction and thegripper 1 will be arranged at its desired location around the heart 1since the opening of the cardiac gripper 1 is arranged to account forthe angled insertion.

In yet an example, the cardiac gripper 1 comprises means for detectionof an electrical signal of the heart and/or means for stimulation of anelectrical signal of the heart. By having the cardiac gripper 1comprising means for detection of an electrical signal of the heartand/or means for stimulation of the electrical signal of the heart, thecardiac gripper 1 is adapted to electrically stimulate and/or sense theelectrical activity of the heart.

In an example, the cardiac gripper 1 treats electrical conductionproblems of the heart by e.g. defibrillation of the heart and/or ECGsynchronized control of the heart.

In an example, the gripper 1 measures the intrinsic heart actionmechanically and electrically and the gripper 1 supplants the rest ofeither modality, or in combination, of which is needed to obtain anormal cardiac output at rest or during exercise. If the heart is movingtoo slowly the gripper senses this and stimulates electrically and ifthere is no response augments mechanically. In an example, the gripper 1performs a cardioversion.

In an example the cardiac gripper 1 comprises at least one pressuresensor that responds to the pressure of the heart. By having thepressure sensor the gripper 1 is adapted to sense a force from the heartmotion and/or sense a counterforce when augmenting the heartmechanically such that e.g. the gripper 1 does not damage the heart byapplying too high pressure to the heart.

In an example, the gripper comprises other types of sensors such astemperature sensors, accelerometers, ultrasound transmitters, ultrasoundreceivers, voltage sensors, potential sensors, current sensors, pHsensors, ECG sensors, ultrasound sensors or ablation sensors. One ormore of these sensors may be integrated into the gripper, e.g. into agripper arm, and arranged to directly or indirectly contact the exteriorof the heart to be supported or mechanically massaged. Some of thesensors may be provided with a contact agent or displacement material,such as water or gel, since some transducers, such as ultrasoundtransducers, preferably should be located a small distance away from theheart wall for imaging and/or to give an improved electrical contact. Inan example, the sensors are distributed at the gripper around the heartallowing for augmentation to be performed at any position around theheart covered by the gripper 1 and/or a net. In an example,electro-diagnosis and/or therapy can be performed at any position of theheart's surface. One or more of the sensors may also communicate, e.g.wirelessly, with a control unit of the gripper.

In an example, the gripper 1 comprises a mesh or net that is arrangedaround the heart and connected to the gripper 1. By having the netconnected to the gripper 1, the gripper 1 and the net is adapted toaugment the heart over a larger area of the heart. In an example the netis mechanically connected to the gripper 1, like a dip net, and followsthe motion of the gripper 1.

In an example, the net and the gripper 1 are connected via a controlunit, controlling them individually to augment the heart mechanically atdifferent areas at, different times and/or at the same the time atdifferent areas.

In example, the heart may have been lifted by a tool such as aspoon-shaped tool or catheter, and the gripper 1 and the net is thenslid around the heart, so as to encompass at least a part of the heart.In an example, the sensors are comprised in the gripper arms 2 of thecardiac gripper 1. With the epicardial access and an additional the netor endocardial basket a simultaneous endocardial and epicardial mappingin 4D can be performed. The 4D mapping can thus find inhomogeneitieswhich point to a source of fibrillation which in some cases can beablated either endocardially or epicardially. In an example,endo-epi-gradients is detected and which points to weak activationtriggers in the heart and the above may thus be treated with the gripper1 and/or gripper 1 comprising the net.

In an example, the cardiac gripper 1 is configured to be deployedintercostally. By having the cardiac gripper 1 configured to be deployedintercostally it can be used in emergency situations by ambulancepersonnel which are then only required to make a simple and quickinsertion at the ribs and the gripper 1 is following deployed throughthe ribs for augmenting the heart. Hence, the size of the cardiacgripper 1 is such that it will fit through the intercostal ribs space.

The implantation takes place through an opening in the skin and isnormally less than 8 mm. However, other sizes of the opening are alsopossible, such as a typical incision ranging between 2-15 mm. It can beperformed by physicians and non-physicians within and outside thehospital, analogous to the implantation of a chest tube.

In an example a method of delivering the cardiac gripper 1 and/oraugmenting system 10 is disclosed. The method comprises an epicardialaccess approach or epicardial access surgery, subcostal access from thesubxyphoid approach, and these are less invasive approaches than otherapproaches that can be used with e.g. VADs.

With the subcostal access, there is enough place above the stomach inthe abdominal fat for storing associated devices to the gripper 1 suchas means for pressurising the cardiac gripper 1, a motor, a battery, acontrol unit. The gripper 1 will then enter through and surround theheart from the apical southward origin.

In an example, the device 1 is also transluminally deliverable to theheart. A sheath or a catheter encompassing the gripper 1 is broughtthrough the left arteria brachialis and advanced further to the targetsite. The target site may be a site, where the device 1 is in contactwith, but exterior to the pericardial sack.

In an example, a cardiac augmenting system 10 is disclosed, e.g.illustrated in FIG. 3-4. The augmenting system 10 comprises a radiallycompressible cardiac gripper 1 for at least mechanical stimulation of aheart and a means for pressurizing 20 the cardiac gripper 1 connectedthereto. By having the gripper 1 connected to the means for pressurizing20 the gripper 1 it is possible to have an automated mechanicalaugmenting of the heart.

The means for pressurizing 20 is in an example one or several motors,one or several pneumatic actuators and/or one or several hydraulicactuators, such as a pump. If the means for pressurizing 20 is apneumatic or hydraulic actuator, it is in an example located exterior tothe body or in an example completely inside the body e.g. at the stomachas described above.

In an example, the augmenting system 10 is configured to be in a relaxedstate such that the system does not introduce any force to heart whennot functioning, i.e. so that no harm is induced to the heart if thegripper 1 or means for pressurizing would fail.

In an example, the means for pressurizing 20 is connected to an inlet 6of the fluid channel arranged at a center between two gripper arms 2 ofthe cardiac gripper 1. By having the means for pressurizing 20 connectedat the center between the gripper arms 2, an evenly distributed pressurewill be achieved in the gripper 1 when it is pressurized so both arms 2will be more or less affected at the same time.

As described above, in an example the gripper 1 comprises triangles, theanalogue of a bellows which consist of an elastic section 3 and acorrugated section 4. As a result when inflated with compressed fluidsuch as air/gas and/or a fluid like sterile water, the gripper 1 will bemoved in an expanding and/or contracting movement for massaging theheart for its blood pumping function.

In an example, the means for pressurizing the cardiac gripper 1comprises a pressure tank formed of a flexible tube, and a step motorwhich is configured to compress and/or expand the flexible tube suchthat fluid flow towards and/or from the cardiac gripper 1. By having aflexible tube and a step motor a cheap, compact and yet reliablepressure solution, augmentation system 10, is achieved.

In an example, the augmenting system 10 comprises means for controllingthe pressure of the means for pressurizing 20. By having means forcontrolling the means for pressurizing 20, the cardiac gripper 1 can beautomated to move in a reciprocating movement, at diastole and/orsystole. The gripper may be synchronized or controlled by a pulsatingblood pressure to be obtained and/or measured. Measurement of the bloodpressure may be done by known methods. A blood pressure signal may beprovided to a control unit of the gripper as an input signal for acontrol feedback loop including actuation of the gripper for mechanicalheart function augmentation.

Systole is the part of the cardiac cycle when the cardiac ventriclescontract. The gripper thus may press on the heart muscle from itsexterior and squeeze the heart ventricles towards the end diastolicpoint of the cardiac cycle. The gripper may also drag the ventriclesinwardly depending on positioning to obtain or enhance the heart'scontraction. Gripper pressure may be synchronized with heart function asdescribed herein.

Diastole is the part of the cardiac cycle when the heart refills withblood following systole. The gripper may actively drag the ventricleoutwardly when attached thereto. The gripper may also push theventricles outwardly depending on positioning to obtain or enhance theheart's refilling expansion. Alternatively or in addition, the gripperpassively relaxes to a end diastolic expanded position. Reciprocatingmotion then starts anew at the next systolic part of the subsequentcardiac cycle. Diastolic relaxation or expansion may be providedsynchronized with heart function as described herein.

In an example, the means for controlling is an internal control unitsuch as an embedded device and/or in an example the means forcontrolling is an external control unit, such as a computer especiallyconfigured for a medical device. The means for controlling is in anexample connected to another control unit by wires or wirelessly, and inan example can either or both of the means for controlling and othercontrol unit also obtain measurements from sensors and/or controlsignals for controlling the gripper 1.

The controls signals sent may be measurement signals, such asmeasurement signals related to magnetic resonance imaging MRI ormagnetic resonance tomography MRT. Another example of measurementsignals is measurement signals related to an electrocardiogram. Bysending measurement signals related to electrocardiograms continuously,an analysis in four dimensions, including time and a three-dimensionalspace, can be performed.

In an example, the means for controlling is configured to provide analternating pressurization of the means for pressurizing 20. Byalternating the pressurization the cardiac gripper 1 will open and closeits arms 2, thus making a reciprocating squeezing movement on the heartfor stimulating it.

In another example, the augmenting system 10 comprises means forelectrically stimulating the heart and/or means for detecting anelectrical signal of the heart. By having the cardiac augmenting system10 comprising means for detecting and/or stimulating the electricalsignal of the heart the system which thus also treats electricalconduction problems at the same time and/or by itself, as the gripper 1gives mechanical stimulation.

In an example, the augmenting system 10 comprises means for controllingthe means for stimulating the electrical stimulation the heart. Byhaving means for controlling the electrical stimulation of the heart itis possible to treat different kinds of electrical conduction problemsautomatically. In an example, the means for controlling the electricalstimulation is, as with the means for controlling the pressure,connected by wires or wirelessly to another control unit.

In an example, the means for controlling the electrical stimulation isbasing its control on a measured electrical activity of the heart and/orECG. In an example, all the means described herein for controlling e.g.electrical stimulation or pressure (mechanical force of the gripperapplied to the heart) is the same means for controlling.

In an example the augmenting system 10 comprises means for transmittingand/or receiving energy and/or data. By having the augmenting system 10comprising means for transmitting and/or receiving energy, a batterycharging of the augmenting system can be done wirelessly through theskin.

Further, by having means for transmitting and/or receiving data thesystem 10 is used in or as a telemetry component wirelessly. Thus, theaugmenting system 10 may has automatic self-control and/or messagingand/or error messaging such as alert of replacement of a component, lowheart pump function and other interesting common heart parameters orparameters of the device. In an example, the augmenting system 10 iscompletely implanted in a patient at the heart and at the stomach, asdescribed above, or in an example at the heart and under the skin at thesame place (shoulder pit) as like a pacemaker is implanted, and remotelywirelessly controlled to mechanically augment and/or electrically detectand/or stimulate the heart.

In an example, the heart gripper 1 is produced with a 3D printer frombiocompatible plastic and which in an example comprises radiopaqueiodine-containing substances or other substances for making the gripper1 visible during X-ray, MRI and/or other imaging techniques.

In an example, illustrated in FIG. 5, a method 100 of treatment byaugmentation of the heart is provided. The method 100 comprisesproviding 110 a cardiac gripper 1 and moving 120 the cardiac gripper 1for augmenting the heart. In an example, the method comprises augmentingthe heart at systole and/or diastole.

In an example the providing 110 of the cardiac gripper 1 is easilyperformed by inserting the cardiac gripper 1 around the heart and thisis due to the at least one gripper arm 2 comprising an angled end, ase.g. illustrated in FIG. 1. In another example, the cardiac gripper 1 iseasily provided 110 at the heart by an open end of the cardiac gripper 1and wherein the open end is opposite of a centre arranged between thegripper arms 2, i.e. the joining of the arms 2 as illustrated in e.g.FIG. 1. By having the open end opposite the centre of the gripper arms2, the gripper arms 2 can more easily and more securely be guided intoplace around the heart since the opening of the gripper 1 is arranged ina steering direction of the cardiac gripper 1.

In an example the providing 110 comprises an operator to produce acounter force, such as a torque or a twisting motion for holding thecardiac gripper 1 at the heart, at its desired location.

In an example the providing 110 is by inserting the cardiac gripper 1 ine.g. an angle.

In an example, the providing 110 of the cardiac gripper 1 is performedby help of an integrated fluid channel or a fluid channel coupled to asteering mean such as a catheter, clamping device and other knownsteering devices such that booth handling, navigation and movement 120of the cardiac gripper 1 is achieved.

In an example, the providing 110 of the cardiac gripper 1 is done bycompletely implanting the cardiac gripper 1 in a patient at the heartand at the stomach, as described above, or in an example at the heartand under the skin at the same place (shoulder pit) as like with apacemaker.

In an example, the cardiac gripper 1 comprises a mesh or net that isalso provided 110 around the heart. By having the net connected to thegripper 1, the gripper 1 and the net is adapted to augment the heartover a larger area of the heart. In an example the net is mechanicallyconnected to the gripper 1, like a dip net, and follows the motion ofthe gripper 1. In an example, the net and the gripper 1 are connectedvia a control unit, controlling them individually to move 120 the heartmechanically at different areas at, different times and/or at the samethe time at different areas.

In example, the heart may have been lifted by a tool such as aspoon-shaped tool or catheter, and the gripper 1 and the net is thenprovided 110 by sliding them around the heart, so as to encompass atleast a part of the heart.

In an example the providing 110 is through an epicardial access. In anexample the epicardial access allows for the cardiac gripper 1comprising the net of performing a simultaneous endocardial andepicardial mapping in 4D. The 4D mapping can thus find inhomogeneitieswhich point to a source of fibrillation which in some cases can beablated either endocardially or epicardially. In an example,endo-epi-gradients is detected and which points to weak activationtriggers in the heart and the above may thus be treated with the gripper1 and/or gripper 1 comprising the net.

In an example, the cardiac gripper 1 is configured to and provided 110to be deployed intercostal.

In an example the method of moving 120 the cardiac gripper 1 isperformed when the natural contractions and/or expansions of the heartoccur. In an example the method of moving 120 the cardiac gripper 1 isperformed such that it substantially restores the heart's movements to anormal degree of contraction and/or expansion.

In an example, the moving 120 of the cardiac gripper 1 has a lowmagnitude and/or force. In an example, the cardiac moving 120 of thecardiac gripper 1 has a high magnitude and/or force.

In an example, the movement 120 is due to at least one of the gripperarms 2 comprising a flexible section 3 which allow the at least one arm2 to move easily outwards and/or inwards for mechanically augmenting theheart.

In an example, the movement 120 of the cardiac gripper 1 is in adirection of a corrugation of the cardiac gripper 1. This is due to thecardiac gripper 1 comprising a corrugated section 4 which is flexible ina direction of the corrugation of the cardiac gripper 1. In an examplethe movement 120 is stiff in a direction perpendicular to the directionof corrugation.

In an example, the movement 120 of the cardiac gripper 1 is chosen to bebased on an interesting area of compression, expansion and/orcontraction of the heart.

In an example, the movement 120 of the cardiac gripper 1 of the at leastone gripper arm 2 is chosen such that the movement if hindered fromcontinuing by the ends of the gripper arms 2 contacting each other.

In an example, the movement 120 of the cardiac gripper 1 is due to thecardiac gripper 1 comprising a fluid channel for pressurising thecardiac gripper 1. In an example the movement 120 is achieved by havingan inlet 6 and wherein the inlet 6 is arranged at the gripper arms 2,e.g. illustrated in FIG. 2. By having the gripper 1 comprising the inlet6 and the inlet 6 being arranged at the gripper arms 2, a pressure of afluid in the fluid channel will be quickly distributed in the fluidchannel in the arms 2 for pushing together or pulling away the gripperarms 2 from each other.

In an example, the movement 120 of the cardiac gripper 1 issubstantially simultaneously for pushing and/or pulling the arms 2 awayand/or together.

In an example, the movement 120 if performed by the cardiac gripper 1comprising the net.

In an example, the movement 120 of the cardiac gripper 1 is performed bya means for pressurizing 20 the cardiac gripper 1 connected thereto. Byhaving the gripper 1 connected to the means for pressurizing 20 thegripper 1 it is possible to have an automated mechanical augmenting ofthe heart.

In an example one or several motors, one or several pneumatic actuatorsand/or one or several hydraulic actuators, such as a pump provides forthe movement 120.

In an example the movement 120 of the cardiac gripper 1 is due to fluidfilling and/or emptying the cardiac gripper 1 by help of thepressurising means 20.

In an example the movement 120 of the cardiac gripper 1 is due to the atleast one motor pulling and/or pushing internally the cardiac gripper 1.

In an example, the movement 120 is in a reciprocating movement, atdiastole and/or systole.

In an example, the method comprises regulating the augmentation based ona control signal. in an example the control signal is based on a sensormeasurement, as also described above. In an example, the regulation isbased on at least an electrical signal of the heart and/or means forstimulation of an electrical signal of the heart. In an example, thegripper 1 measures the intrinsic heart action mechanically and/orelectrically and the gripper 1 supplants the rest of either modality, orin combination, of which is needed to obtain a normal cardiac output foran activity such as resting or during exercise.

In an example, the cardiac gripper 1 treats electrical conductionproblems of the heart by e.g. defibrillation of the heart and/or ECGcontrol of the heart. In an example, the heart is moving too slowly orto fast and the gripper senses this and stimulates electrically, but ifthere is no response the cardiac gripper 1 augments mechanicallyinstead. In an example, the gripper 1 performs a cardioversion.

In an example the regulation of the cardiac gripper 1 is in response tothe pressure of and/or from the heart.

In other examples, the cardiac gripper 1 is regulated by other types ofsensors and/or signals therefrom such as temperature sensors,accelerometers, ultrasound transmitters, ultrasound receivers, magneticresonance imaging (MRI), magnetic resonance tomography (MRT), voltagesensors, potential sensors, current sensors, pH sensors, ECG sensors,ultrasound sensors or ablation sensors. Some of the sensors may beprovided with a contact agent or displacement material, such as water orgel, since some of the sensors, such as ultrasound, preferably should belocated a small distance away from the heart wall for imaging and/or togive an improved electrical contact.

In an example, electro-diagnosis and/or therapy can be performed at anyposition of the heart's surface.

In an example the regulation is controlled by a specialised medicalcomputer, a medical embedded computer or the like connected to thecardiac gripper 1 by wires or wirelessly.

In an example, the means for controlling is configured to provide analternating pressurization of the means for pressurizing 20. Byalternating the pressurization the cardiac gripper 1 will open and closeits arms 2, thus making a reciprocating squeezing movement on the heartfor stimulating its pumping action. In examples this is performed atpredetermined times, for a duration of time or triggered by specificevents detected in the sensor signals.

TABLE 1 comparison between different modalities Conventional CPR GripperContraction On solid ground only Resuscitation without ground possiblePossible only in supine position Possible in any posture, placement insupine and sitting position Needs several persons over Needs only oneperson longer time Quality decreases with time Quality remains stableComplex procedure Simple procedure Remains in the hands of first Can betransfered to a machine rescuers Rib fracture is a must No rib fracturePneumothorax possible Pneumothorax possible Difficult transport ofpatient Simple transport of patient Infection rare Infection possibleSuccess rate <20% Success rate >20% Needs full concentration ofAutomatic alarm with problems rescuers In acute situation only In acuteand chronic situation Conventional LVAD Gripper contraction Blood flowcontinuous Blood flow pulsatile Maximal flow 10 l 20 l Cannotdefibrillate Can defibrillate Cannot cool Is able to cool Direct bloodcontact No direct blood contact Implantation time: 1-2 hours SecondsImplanteur: surgeon and team One primary care person Possiblecomplication: AI Ø AI Possible complication: Infection InfectionDriveline: yes Completely implantable with battery and TET ECKG: no YesTelemetry: yes Yes Completely implantable: no Yes Cost: >110.000€ <500 €Possible complication: stroke Ø stroke Induced coagulation abnormality:No coagulation abnormality FVIII deficiency expected Not applicablewithout specialized Can be used everywhere (e.g. unit ambulance car)Chronic application only Chronic and acute application Antikoagulationnecessary Anticoagulation not necessary Durability several yearsDurability unknown Replacement very demanding Replacement easy Only LVsupport (+RV?) LV + RV support Right heart failure as possible Rightheart failure unlikely since complication both ventricles are supported

The present disclosure has been described above with reference tospecific examples. However, other examples than the above described areequally possible within the scope of the disclosure. The differentfeatures and steps of the disclosure may be combined in othercombinations than those described. The scope of the disclosure is onlylimited by the appended patent claims. More generally, those skilled inthe art will readily appreciate that all parameters, dimensions,materials, and configurations described herein are meant to be exemplaryand that the actual parameters, dimensions, materials, and/orconfigurations will depend upon the specific application or applicationsfor which the teachings of the present disclosure is/are used.

1. A radially compressible cardiac gripper for at least mechanicalstimulation of a heart, wherein the cardiac gripper comprises twogripper arms, and wherein at least one of the gripper arms comprises aflexible section configured for movement of the arm.
 2. The cardiacgripper according to claim 1, wherein the at least one gripper arm isconfigured to be pressurized and moved by a fluid.
 3. The cardiacgripper according to claim 2, wherein at least one of the gripper armscomprise a corrugated section.
 4. The cardiac gripper according to claim2, wherein at least one of the gripper arms comprise a sinusoidalsurface, and wherein the sinusoidal surface is angled towards a centerpoint of the cardiac gripper.
 5. The cardiac gripper according to claim2, wherein the cardiac gripper comprises a fluid channel having an inletand wherein the inlet is arranged at the gripper arms.
 6. The cardiacgripper according to claim 5, wherein the inlet is arranged at a centerbetween the gripper arms.
 7. The cardiac gripper according to claim 2,comprising an open end and wherein the open end is opposite of a centerof the gripper arms.
 8. The cardiac gripper of claim 1, wherein thecardiac gripper comprises means for detection of an electrical signal ofthe heart and/or means for stimulation of an electrical signal of theheart.
 9. The cardiac gripper of claim 1, wherein the cardiac gripper isconfigured to be deployed intercostal.
 10. A cardiac augmenting systemcomprising; a radially compressible cardiac gripper for at leastmechanical stimulation of a heart, a means for pressurizing the cardiacgripper connected thereto.
 11. The cardiac augmenting system accordingto claim 10, wherein the means for pressurizing is connected to an inlet(6) of a fluid channel arranged at a center of a flexible section (2) ofthe cardiac gripper (1).
 12. The cardiac augmenting system according toclaim 10, wherein the augmenting system comprises means for controllingthe pressure of the means for pressurizing.
 13. The cardiac augmentingsystem according to claim 10, wherein the means for controlling thepressure is configured to provide an alternating pressurization of themeans for pressurizing.
 14. The cardiac augmenting system according toclaim 10, wherein the augmenting system comprises means for electricallystimulating the heart and/or means for detecting an electrical signal ofthe heart.
 15. The cardiac augmenting system according to claim 10,wherein the augmenting system comprises means for controlling theelectrical stimulation the heart.